Olon SpA
Form 483 issued September 13, 2019 · Rodano, Italy
- Inspection
- Sep 9 – Sep 13, 2019
- Investigator
- Camerson E. Moore
- Observations
- 1
- Pages
- 1
- FEI number
- 3002716636
In short: On September 13, 2019, FDA issued a Form 483 with 1 observation to Olon SpA in Rodano, MI (FEI 3002716636) after an inspection that ran Sep 9 – Sep 13, 2019. The investigator was Camerson E. Moore. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to ensure the accuracy and integrity of the electronic data…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmOlon SpA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Olon SpA?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Olon SpA?
Camerson E. Moore is named on this Form 483, for the inspection of Sep 9 – Sep 13, 2019. Each investigator has a profile showing what they cite most.
When was Olon SpA inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2019, and the Form 483 is dated September 13, 2019.
How do I get the full Form 483 for Olon SpA?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.